510(k) Report

Devices descending from K111231

11 later devices reach Panoura 18S through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd.20136—
+1K122806Image Works PanouraMic International20132—
+1K121800Point 500 HD POINT500C HDPointnix Co., Ltd.20130—
+2K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.20191—
+2K161881PreXion3D ExcelsiorPrexion Corporation20162—
+2K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp.20162—
+3K222666X-View 3D Pan/X-View 2D PanTrident S.R.L20230—
+3K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica20211—
+3K173878PreXion3D ExcelsiorPrexion Corporation20181—
+4K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica20230—
+4K181983PreXion 3D ExcelsiorPrexion Corporation20180—